DRAFT Justification document for the inclusion of nano-related activities in the SAICM Global Plan of Action

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DRAFT April 3rd 2011,

Proposal from the government of Switzerland

Justification document for the inclusion of nano-related activities in the SAICM Global Plan of Action

Complementing the Strategic Approach to International Chemicals Management Global Plan of Action with the creation of a new work area and associated activities in relation to the environmentally sound management of nanotechnologies and manufactured nanomaterials.

The use of nanotechnologies and manufactured nanomaterials has evolved rapidly since the first session of the International Conference on Chemical Management in 2006. Today, these new technologies are broadly used, and heavy research and development is underway in many countries. Nanotechnologies and manufactured nanomaterials offer potential societal and economical benefits as well as potential environmental, health and safety risks.

Nanotechnologies and manufactured nanomaterials were not yet an issue at first session of the International Conference on Chemical Management, but they were addressed as an emerging issue under SAICM beginning with the second session of the International Conference on Chemical management (ICCM2) in 2009. The SAICM Global Plan of Action (GPA) thus does not yet address this issue. Switzerland is proposing to add a new work area to the Global Plan of Action, with new activities for the sound management of nanotechnologies and manufactured nanomaterials, at the third International Conference on Chemical Management (ICCM3) in 2012.

The proposed new work area includes activities to:

  • Encourage the generation and sharing of hazard and risk data in relation to nanomaterials and nanotechnologies;
  • Support technical, legal and institutional information sharing and capacity building for the management of nanomaterials;
  • Integrate the management of nanomaterials to ongoing and projected chemical management programs;
  • Support the development of adequate risk management tools and mechanisms, including information schemes such as certification systems.

See table 1 below.

In accordance with the procedure adopted during ICCM2, this draft document describes how the activities of the proposed new work area are relevant to protecting human health and the environment; its contribution to national, regional or global commitments, objectives, priorities, and needs; how it will reflect best practices and be effective; and, means of implementation at the country or participant level.

Background information, including relevance of the activity to protecting human health and the environment

The background information (SAICM/ICCM.2/INF/34) in relation to the emerging policy issue of nanotechnology and manufactured nanomaterials document, that was prepared to guide the discussion on this emerging issue and provide rationale for proposed cooperative action during ICCM2 noted that “while SAICM is aimed to providing the overarching policy framework for chemicals policy and sound chemicals management, it does not yet address this increasingly important area of chemicals management”[1].

The same document mentions that some of the same unique properties that make manufactured nanoparticles suitable for certain applications also raise questions about the impacts of nanoparticles on human health and the environment. Toxicity and fate of nanoparticles depends on a variety of physicochemical properties such as size and shape, as well as surface properties such as charge, area, reactivity, and coating type on the particle. These factors also influence the uptake and distribution of nanoparticles in the human body.In addition to particles themselves, the potential human health and ecological impacts of their breakdown products, as well as their interactions with other contaminants, should also be considered.

Once in the bloodstream, studies have shown that some nanoparticles can be transported around the body and are taken up by the liver, spleen, bone marrow, the kidneys, the heart, the reproductive organs, soft tissue and skeleton.[2]Furthermore, placental transfer is supported by a recent study, which demonstrated the ability of some nanoparticles to transfer from pregnant mice into the brain and testes of their offspring[3]. A number of studies have also demonstrated that some nanoparticles may be transported directly from olfactory neurons into the central nervous system, crossing the blood-brain barrier.

With respect to the genotoxicity of nanomaterials, studies have shown the ability of nanomaterials to penetrate sub-cellular compartments containing DNA that are usually impervious to man-made chemicals. The intracellular mobility of nanomaterials is especially concerning when viewed in light of studies showing that nanomaterials can, directly and/or indirectly (through oxidative stresses), damage DNA, RNA, and/or histones.[4]

In addition, there is evidence that some nanomaterials may be toxic for ecosystems. For example, nanoscale titanium dioxide can cause mortality or behavioral or physiological changes in environmental indicator species such as water fleas, fish, or algaeand have been shown to stress photosynthetic organisms, potentially leading to the disruption of nitrogen and carbon cycles in aquatic ecosystems.[5]

When chemicals bioaccumulate, tissue concentrations increase over time despite low background environmental levels of the chemical. The U.S. Environmental Protection Agency (U.S. EPA) acknowledged that “[b]acteria and living cells can take up nanosized particles, providing the basis for potential bioaccumulation in the food chain.”[6] Further research has shown that earthworms can absorb copper nanoparticles present in soil.[7] Biomagnification, the increase in concentration of a specific toxic from prey into predator, was also evidenced for nanomaterials in an aquatic environment, involving microscopic life forms, which comprise the base of all food webs.[8]This evidence of bioaccumulation suggests that the risks of nanomaterials to human health and the environment may increase over time.

Additionally, According to the U.S. EPA Nanotechnology White Paper, “[m]any of the nanomaterials in current use are composed of inherently non-biodegradable inorganic chemicals, such as ceramics, metals and metal oxides, and are not expected to biodegrade.”[9]

Because manufactured nanomaterials are already on the market in a growing number of products including paints, cosmetics, clothing, household appliances, food packaging, etc. countries should give due consideration to potential health or environmental implications of such use of nanomaterials during their whole life cycle; e.g. the potential effects of production of the nanoscale materials, as well as the disposition of nanomaterials that may, for example, require new hazard communication programs to recyclers or new concerns for disposal.[10] In this context, according to ICCM2 preparatory documents, SAICM should provide a supportive international framework to support developing countries and countries with economies in transition to develop and implement concrete policies and activities[11].

The new GPA activities in relation to nanotechnologies and manufactured nanomaterials herein proposed by Switzerland could thus help countries to address this issue, to develop and implement appropriate policies, and to access support for such policies.

How the activity would contribute to achieving national, regional or global commitments, objectives, priorities and needs

SAICM’s general objectives are detailed in the Overarching Policy Strategy (OPS) and Dubai Declaration. These overall objectives include risk reduction, knowledge and information, Governance and capacity building and technical cooperation. The GPA is the evolving tool that identifies work areas and associated activities that may be undertaken by stakeholders in order to pursue the commitments and objectives expressed in the SAICM OPS and the Dubai Declaration. The proposed new work area aims at providing an implementation path to reach the OPS objectives in relation to nanotechnologies and manufactured nanomaterials.

During ICCM2, a resolution on nanotechnologies and manufactured nanomaterials was adopted. This resolution called on SAICM stakeholders to provide support to countries in development and countries with economies in transition to enhance their capacity to use and manage nanotechnologies and manufactured nanomaterials responsibly (operational paragraph 1), and on the wider dissemination of human health and environmental safety information in relation to products containing nanomaterials (operational paragraph 7). The resolution also requested the promotion of appropriate actions to safeguard human health and the environment (OP 2), recognized the role of regulatory, voluntary and partnership approaches for the responsible management of nanotechnologies and manufactured nanomaterials (OP3) and recommended the establishment of multi-stakeholder dialogues (OP 6). New GPA activities proposed for inclusion in the new work area relating to nanotechnologies and manufactured nanomaterials would support the realization of these objectives.

At subsequent SAICM regional meetings, in Africa and Latin America and Caribbean regions further elaborated on specific national and regional needs in relation to the safe management of nanotechnologies and manufactured nanomaterials through specific resolutions. Those needs relate to the establishment of partnerships and collaborations; to the necessary funding for research on potential risks to human health and the environment; to the development of legal provisions to ensure safe practices with regards to the production, use, transport and disposal of manufactured nanomaterials.

The new activities that Switzerland proposes to add to the SAICM GPA, are designed to support the fulfillment of those needs and priorities, as adopted unanimously by the African and GRULAC regions.

For example, in order to satisfy the demand for the set up and enforcement of legal provisions to ensure safe practices with regards to all stages of nanomaterials life, Switzerland proposes to include activities to assess the gaps in existing regulatory and institutional frameworks, promote and enhance information sharing on national and regional policy and regulatory initiatives, identify, strengthen and enforce legal and regulatory provision for the environmentally sound management of waste containing nanomaterials, and promote consensus standards.

Similarly, to meet the needs expressed by those regions and countries for better information regarding potential human health and environmental impacts of manufactured nanomaterials and, Switzerland proposes to add activities to increase the understanding of the environmental health and safety implications through further information sharing and research of manufactured nanomaterials.

Ways in which the activity reflects the best practices and will be effective

The activities included in the proposed new work area on nanotechnologies and manufactured nanomaterials intend to facilitate the sharing of best practices, including by facilitating the exchange of information on existing regulatory and voluntary initiatives, for example in the area of protection of workers manufacturing, using or disposing of manufactured nanomaterials.

Furthermore, by promoting sharing of technical and regulatory information, it would allow countries less advanced to benefit from knowledge developed by most advanced countries, arising in particular from existing regional initiatives such as the OECD Working party on Manufactured Nanomaterials and definition efforts from the European Union and International Standardization Agency.

Means of implementation of the activity at the country or participant level (Setting out examples)

Activities proposed, such as promoting private/public partnership, including nanomaterials and nanotechnology in existing chemical management programs, refining guidance for such inclusion and developing pilot projects in developing countries and countries with economies in transition, developing nano labeling schemes based on best practices, could provide appropriate means of implementation at the country or participant level.

Proposal for inclusion of new activities under a new work area relating to nanotechnologies and manufactured nanomaterials:

DRAFT Justification document for the inclusion of nano-related activities in the SAICM Global Plan of Action

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Work Area / New Activity / Actors / Target/Time frame / Indicators of progress / Implementation aspects
Nanotechnologies and Manufactured nanomaterials / Increasing the understanding of the environmental health and safety implications through further information sharing and research of manufactured nanomaterials. / National governments,
Intergovernmental and international organizations, industry, NGO / 2012 – 2015 / Number of publicly available research paper on hazards and risks, significantly increase. All stakeholders are informed of risks and hazards of nanomaterials. / Coordination by IOMC
Support and where feasible, increase funding for research on nanotechnologies health and safety implications / National governments,
Intergovernmental and international organizations, industry, NGO / 2012 – 2020 / Number of publicly available research paper on hazards and risks, significantly increase.
Promote public and private sectors partnerships for the environmental sound management of nanomaterials / National governments,
Intergovernmental and international organizations, industry, NGO / 2012 – 2015 / Number of public/private partnerships signed.
Establish partnerships, with consideration of financial support, to assist developing countries and countries with economies in transition to build scientific, technical, legal, and regulatory policy expertise related to the risks of manufactured nanomaterials. / National governments,
Intergovernmental and international organizations, industry, NGO / 2012 – 2015 / Number of partnership established.
Further refine existing guidance on incorporation of nano in chemicals management programs, and identifying where gaps exist. / National governments,
Intergovernmental and international organizations, industry, NGO / 2012 – 2015 / Nanomaterials are included in increasing number of chemical management programs
Incorporate nanomaterials and nanotechnologies in national chemicals management program / National governments,
Intergovernmental and international organizations, industry, NGO / 2012 – 2015 / Nanomaterials are included in increasing number of chemical management programs
Assess gaps in existing legal and institutional framework addressing nano specific issues. Establish national policy and institutional coordination plan. / National governments,
Intergovernmental and international organizations, industry, NGO / 2012 – 2015 / Reports on regulatory and institutional gaps;
Enhance information sharing on national, and regional policy and regulatory initiatives / National governments,
Intergovernmental and international organizations, industry, NGO / 2012 – 2015 / All stakeholders are informed of risks and hazards of nanomaterials. All relevant stakeholders have access to available relevant information
Identify, strengthen and enforce legal and regulatory provision for the environmentally sound management of waste containing nanomaterials / National governments,
Intergovernmental and international organizations, industry, NGO / 2012 – 2015 / Relevant legislation or/and best practices are in place and implemented in all relevant sectors.
Consider legislation to protect workers and the public, covering the entire spectrum of work situations in which nanomaterials are handled / National governments,
Intergovernmental and international organizations, industry, NGO / 2012 – 2015 / Relevant legislation is fully implemented in all relevant sectors.
Promoting consensus standards on nanotechnologies and manufactured nanomaterials / National governments,
Intergovernmental and international organizations, industry, NGO / 2012 – 2017 / Standards are developed.
Develop nano labeling schemes / National governments,
Intergovernmental and international organizations, industry, NGO / 2012 – 2015 / Nano product labels developed
Development of a global certification schemes / National governments, Intergovernmental and international organizations, industry, NGO / 2012-2020 / Certification scheme is developed.
Improve existing information management system to include nano specific information / National governments,
Intergovernmental and international organizations, industry, NGO / 2012 – 2015 / MSDS includes relevant nano information. Databases are developed.

[1]Background information in relation to the emerging policy issue of nanotechnology and manufactured nanomaterials, note by the secretariat, SAICM/ICCM.2/INF/34, available at

[2] SCENIHR, Risk Assessment of Products of Nanotechnologies, pgs 24-29 (2009) (citing several science-based studies) available at

[3]Takeda et al., Nanoparticles Transferred from Pregnant Mice to Their Offspring Can Damage the Genital and Cranial Nerve Systems, Journal of Health Science, Volume 55, number 1, February 2009

[4]Id., pg 32 (referencing Gonzalez et al 2008 and Landsiedel et al 2008).

[5]See e.g. Carla Cherchi and April Z. Gu, Impact of Titanium Dioxide nanomaterials on Nitrogen Fixation rate and intracellular Nitrogen storage in Anabaena Variabilis, 2010, Environ. Sci. Technol., 2010, 44 (21), pp 8302–8307, available at

[6] U.S. EPA, Nanotechnology White Paper, at p. 50 (2007), available at (citing Biswass and Wu, 2005).

[7]Jason M. Unrine, Olga V. Tsyusko, Simona E. Hunyadi, Jonathan D. Judy, Paul M. Bertsch. Effects of Particle Size on Chemical Speciation and Bioavailability of Copper to Earthworms Exposed to Copper Nanoparticles. 2010, Journal of Environment Quality, 2010; 39 (6): 1942, available at 10.2134/jeq2009.0387.

[8]R. Werlin, J. H. Priester, R. E. Mielke, S. Krämer, S. Jackson, P. K. Stoimenov, G. D. Stucky, G. N. Cherr, E. Orias, P. A. Holden. Biomagnification of cadmium selenide quantum dots in a simple experimental microbial food chain. Nature Nanotechnology, 2010; DOI:10.1038/nnano.2010.251, available at

[9] U.S. EPA, Nanotechnology White Paper, supra note 15, at p. 50.

[10]See supra note i.

[11]See supra note i.